PMA P110010S137

Device: PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P110010
Supplement: S137
Product code: NIQ
Decision date: 2017-03-23
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: Approval for a manufacturing site located at Boston Scientific Maple Grove, Two Scimed Place, Maple Grove, Minnesota for the Poly n-Butyl Methacrylate (PBMA) purification of the Promus PREMIER Stent system

Current openFDA PMA Record#

Device: PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant: Boston Scientific Corp
PMA number: P110010
Supplement: S137
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2017-03-23
Decision code: APPR
Date received: 2016-12-05
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Boston Scientific Maple Grove, Two Scimed Place, Maple Grove, Minnesota for the Poly n-Butyl Methacrylate (PBMA) purification of the Promus PREMIER Stent system